NCT05186753Phase 2Active not recruiting

(Summit) A Study to Evaluate the Efficacy and Safety of CGT9486 Versus Placebo in Patients With Indolent or Smoldering Systemic Mastocytosis

Study sponsor: Cogent Biosciences, Inc. · COGT

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2025-05-22Actual

Enrollment · participants237Estimated

Source updated2026-05-22Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Posted 2025-10-29 · 3 fields changed

Planned enrollment increased by 30 participants

− Before

~~207 participants (planned)~~

+ After

237 participants (planned)

Completion date type changed

− Before

~~Estimated~~

+ After

Actual

Primary completion date changed

− Before

~~Sep 2025~~

+ After

22 May 2025

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Study details

Conditions studied

SSM; Mastocytosis, Indolent; Mastocytosis, Systemic; Mastocytosis; ISM; BMM; Smoldering Systemic Mastocytosis; Bone Marrow Mastocytosis

Treatments or interventions studied

Bezuclastinib Tablets (Formulation A)DrugAlso known as CGT9486, PLX9486
Bezuclastinib Tablets (Formulation B)DrugAlso known as CGT9486, PLX9486
Placebo TabletsDrug

Primary outcomes · main study measures

Read the study measures

measure: Part 1: Determine recommended dose of bezuclastinib (CGT9486) in subjects with NonAdvSM; description: Selection of the recommended dose to be used in subsequent parts of the study.; timeFrame: 3 months; measure: Part 2: Efficacy of bezuclastinib at the selected dose versus placebo; description: Mean absolute change on the Mastocytosis Symptom Severity Daily Diary (MS2D2); timeFrame: 24 Weeks; measure: Part 3: Safety and tolerability of bezuclastinib as assessed by number of adverse events; description: CTCAE v5; timeFrame: Up to 5 years

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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